Biograstim

filgrastim

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The marketing authorisation for Biograstim has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Biograstim : EPAR - Summary for the public BG = bălgarski 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public ES = español 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public CS = čeština 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public DA = dansk 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public DE = Deutsch 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public ET = eesti keel 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public EL = elliniká 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public EN = English 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public FR = français 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public IT = italiano 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public LV = latviešu valoda 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public LT = lietuvių kalba 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public HU = magyar 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public MT = Malti 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public NL = Nederlands 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public PL = polski 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public PT = português 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public RO = română 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public SK = slovenčina 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public SL = slovenščina 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public FI = suomi 2008-09-29 2017-01-19
Biograstim : EPAR - Summary for the public SV = svenska 2008-09-29 2017-01-19

This EPAR was last updated on 19/01/2017 .

Authorisation details

Product details

Product details for Biograstim
NameBiograstim
Agency product numberEMEA/H/C/000826
Active substance

filgrastim

International non-proprietary name (INN) or common name

filgrastim

Therapeutic area NeutropeniaHematopoietic Stem Cell TransplantationCancer
Anatomical therapeutic chemical (ATC) code L03AA02
Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Biograstim
Marketing-authorisation holder

AbZ-Pharma GmbH

Revision8
Date of issue of marketing authorisation valid throughout the European Union15/09/2008

Contact address:

AbZ-Pharma GmbH
Graf -Arco-Strase 3
99079 Ulm
Germany

Product information

Product information

23/09/2015  Biograstim -EMEA/H/C/000826 -IB/0029

Name Language First published Last updated
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - Product Information SV = svenska 2009-11-09 2017-01-19

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19
Biograstim : EPAR - All Authorised presentations SV = svenska 2009-11-09 2017-01-19

Pharmacotherapeutic group

Colony-stimulating factors

Therapeutic indication

Biograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.

Biograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).

In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of Biograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

Biograstim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Biograstim : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2009-11-09 2017-01-19

Initial marketing-authorisation documents

Name Language First published Last updated
Biograstim : EPAR - Public assessment report SV = svenska 2008-09-29 2017-01-19
Committee for medicinal products for human use summary of positive opinion for Biograstim SV = svenska 2008-07-25 2017-01-19

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Biograstim

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